A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

• ClinicalTrials.gov Identifier: NCT00115908
• Recruitment Status: Completed
• First Posted: June 27, 2005
• Last Update Posted: November 7, 2013
• Sponsor: Human Genome Sciences Inc.
• Information provided by (Responsible Party): Human Genome Sciences Inc.

Tracking Information

• First Submitted Date: June 26, 2005
• First Posted Date: June 27, 2005
• Last Update Posted Date: November 7, 2013
• Study Start Date: May 2005
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 20, 2011): Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy.

Original Primary Outcome Measures (submitted: June 29, 2005)

• Sustained virologic response (SVR), defined as undetectable
• HCV RNA at 24 weeks after the end of therapy

Current Secondary Outcome Measures (submitted: June 29, 2005)

• Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
• Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA.
• Undetectable HCV RNA at Week 24.
• End of treatment response (ETR), defined as undetectable HCV RNA at Week 48

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
• Official Title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1
• Brief Summary: The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatitis C, Chronic

Intervention

• Drug: Albuferon
• Drug: Ribavirin
• Drug: PEG-IFNalfa2a

• Study Arms: Not Provided

Publications *

• Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.
• Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2011): 458
• Original Enrollment (submitted: June 29, 2005): 460
• Actual Study Completion Date: May 2007
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1.
• Compensated liver disease

Key Exclusion Criteria:

• Pregnant or lactating female or males with a pregnant partner.
• A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg).
• A history of moderate, severe or uncontrolled psychiatric disease.
• A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Czech Republic, France, Germany, Israel, Poland, Romania

Administrative Information

• NCT Number: NCT00115908
• Other Study ID Numbers: ALFR-HC-04
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Human Genome Sciences Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Human Genome Sciences Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: Human Genome Sciences Inc.
• Verification Date: November 2013